Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000112369
Ethics application status
Approved
Date submitted
14/12/2016
Date registered
23/01/2017
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
TextNudge an automated text messaging intervention to encourage and support activity after discharge from physiotherapy.
Scientific title
TextNudge, an automated text messaging intervention to encourage and support activity after discharge form physiotherapy: a feasibility and acceptability study
Secondary ID [1] 290762 0
None
Universal Trial Number (UTN)
U1111-1190-9765
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Post-discharge from physiotherapy 301363 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301112 301112 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An automated text-messaging intervention to encourage and support exercise and activity after discharge from physiotherapy. The physiotherapist will select from one of a number of different packages of text messages. Each of the packages will contain a total of 44 texts of pre-written text messages. The text packages will take in to account patient preference of the type of encouragement they find most appropriate and will also look at the basic type of exercise or activity the patient has been prescribed, selected from ‘general encouragement’, ‘general arm exercise nudges’ ‘general leg exercise nudges’ and ‘general fitness nudges’. The TextNudge intervention will run for 12 weeks and messages will be sent daily for the first 4 weeks of the programme then 3 times per week for the remaining 8 weeks. Texts will be reminders to continue with pre-arranged exercises. A disclaimer will accompany the first text explaining that texts do not take the place of medical advice and to seek help if new problems occur.
Intervention code [1] 296669 0
Behaviour
Intervention code [2] 296670 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300517 0
Semi-structured interview to explore participant satisfaction with TextNudge.
Timepoint [1] 300517 0
At the end of the 12-week intervention
Secondary outcome [1] 330190 0
A telephone interview will be undertaken to ask general questions about the patient experience of receiving TextNudge. The telephone interview will ascertain if they received texts or stopped them, if the number and content was appropriate and whether the texts affected their activities in any way. In addition patients will be asked to make comments and suggestions about possible improvements to the programme.
Timepoint [1] 330190 0
At the end of the 12-week intervention
Secondary outcome [2] 330191 0
A log of the number of potential participants and the number of actual participants recruited in the 4-week recruitment period.
Timepoint [2] 330191 0
Throughout the 4-week recruitment period.
Secondary outcome [3] 330956 0
A telephone interview will be undertaken with the physiotherapist who instituted the programme at patient discharge. They will be asked whether setting up TextNudge was a burden and if they think it may be a useful adjunct to practice. In addition physiotherapists will be asked to make comments and suggestions about possible improvements to the programme.
Timepoint [3] 330956 0
At the end of the 12-week intervention

Eligibility
Key inclusion criteria
Physiotherapist participants: all those who are discharging patients from physiotherapy treatment in to the community during the 4-week recruitment period, within Waitemata DHB.
Patient participants: all those who are discharged by participating physiotherapists during the 4-week recruitment period, who live in the community.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The inability to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
16/07/2017
Date of last participant enrolment
Anticipated
25/01/2018
Actual
16/02/2018
Date of last data collection
Anticipated
10/05/2018
Actual
16/05/2018
Sample size
Target
40
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 8506 0
New Zealand
State/province [1] 8506 0
Auckland

Funding & Sponsors
Funding source category [1] 295188 0
University
Name [1] 295188 0
Auckland University of Technology
Country [1] 295188 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90, Akoranga Drive, Northcote, Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 294016 0
None
Name [1] 294016 0
Address [1] 294016 0
Country [1] 294016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296539 0
Health and Disability Ethics committee
Ethics committee address [1] 296539 0
Ethics committee country [1] 296539 0
New Zealand
Date submitted for ethics approval [1] 296539 0
10/01/2017
Approval date [1] 296539 0
08/03/2017
Ethics approval number [1] 296539 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71210 0
Dr Nicola Saywell
Address 71210 0
Auckland University of Technology, 90, Akoranga Drive, Northcote, Auckland 0627
Country 71210 0
New Zealand
Phone 71210 0
+6499219502
Fax 71210 0
Email 71210 0
[email protected]
Contact person for public queries
Name 71211 0
Nicola Saywell
Address 71211 0
Auckland University of Technology, 90, Akoranga Drive, Northcote, Auckland 0627
Country 71211 0
New Zealand
Phone 71211 0
+6499219502
Fax 71211 0
Email 71211 0
[email protected]
Contact person for scientific queries
Name 71212 0
Denise Taylor
Address 71212 0
Auckland University of Technology, 90, Akoranga Drive, Northcote, Auckland 0627
Country 71212 0
New Zealand
Phone 71212 0
+6499219680
Fax 71212 0
Email 71212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not given permission for data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.